U.S. patent application number 16/317251 was filed with the patent office on 2021-10-28 for dose detection module for a medication delivery device.
The applicant listed for this patent is Eli Lilly and Company. Invention is credited to Roy Howard BYERLY, Rossano MASSARI, Davide PACCIORETTI.
Application Number | 20210330891 16/317251 |
Document ID | / |
Family ID | 1000005726350 |
Filed Date | 2021-10-28 |
United States Patent
Application |
20210330891 |
Kind Code |
A1 |
BYERLY; Roy Howard ; et
al. |
October 28, 2021 |
DOSE DETECTION MODULE FOR A MEDICATION DELIVERY DEVICE
Abstract
The present disclosure relates to a dose detection system and
method for a medication delivery device. The dose detection system
may include a dosing component attached to an actuator and
rotationally and axially moveable relative to a coupling component
attached to a dose setting member. The dose detection system may
further comprise a module including an electronic sensor operative
to detect a relative rotation of the coupling component and the
dosing component to detect a dose delivered by the medication
delivery device.
Inventors: |
BYERLY; Roy Howard;
(Indianapolis, IN) ; MASSARI; Rossano; (Lissone
(MB), IT) ; PACCIORETTI; Davide; (Samarate (VA),
IT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Eli Lilly and Company |
Indianapolis |
|
IN |
|
|
Family ID: |
1000005726350 |
Appl. No.: |
16/317251 |
Filed: |
July 7, 2017 |
PCT Filed: |
July 7, 2017 |
PCT NO: |
PCT/US2017/041081 |
371 Date: |
January 11, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62362808 |
Jul 15, 2016 |
|
|
|
62466658 |
Mar 3, 2017 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 5/31568 20130101;
A61M 2205/3306 20130101; A61M 5/31551 20130101; A61M 2205/3327
20130101; A61M 5/31585 20130101 |
International
Class: |
A61M 5/315 20060101
A61M005/315 |
Claims
1. A medication delivery device for detecting the amount of a drug
dose delivery comprising: a device body; a dose setting member
attached to said device body and rotatable about an axis of
rotation relative to said device body, said dose setting member
moving axially and rotating relative to said device body during
dose setting and during dose delivery; an actuator attached to said
device body, said actuator moving axially and rotating with said
dose setting member relative to said device body during dose
setting, said actuator moving axially and non-rotatably relative to
said device body during dose delivery, said dose setting member
rotating relative to said actuator during dose delivery in relation
to the amount of dose delivered; a coupling component axially and
rotationally fixed to said dose setting member; a dosing component
having a first operating mode during dose setting in which said
dosing component is axially and rotationally fixed to said coupling
component, said dosing component having a second operating mode
during dose delivery in which said coupling component is rotatable
relative to said dosing component and in which said dosing
component is axially and rotationally fixed to said actuator; and
an electronics assembly including a rotation sensor operative to
detect rotation of said coupling component relative to said dosing
component during dose delivery.
2. The medication delivery device of claim 1 in which said coupling
component is not in contact with said dosing component in the
second operating mode.
3. The medication delivery device of claim 1 in which said dose
setting member includes an exposed circumferential surface for use
in rotating said dose setting member relative to said device body,
said dosing component including an inner wall and an outer wall,
said coupling component including a coupling wall received between
the inner and outer walls, said coupling component extending
distally beyond the inner wall and including a coupling portion
attached to the exposed circumferential surface of the dose setting
member.
4. The medication delivery device of claim 3 in which the outer
wall extends distally to radially overlap at least a portion of the
exposed circumferential surface of said dose setting member.
5. The medication delivery device of claim 3 in which the inner and
outer walls of said dosing component are axially movable relative
to the coupling wall of said coupling component.
6. The medication delivery device of claim 3 and further comprising
a locking mechanism operative to rotationally lock said coupling
component with said dosing component in the first operating
mode.
7. The medication delivery device of claim 6 in which the locking
mechanism is operative to rotationally lock the coupling wall of
said coupling component with one of the inner and outer walls of
said dosing component.
8. The medication delivery device of claim 1 and further comprising
a locking mechanism operative to rotationally lock said coupling
component with said dosing component in the first operating
mode.
9. The medication delivery device of claim 8 in which distal axial
movement of said dosing component relative to said device body is
operative to disengage the locking mechanism to allow rotation of
said coupling component relative to said dosing component.
10. The medication delivery device of claim 9 in which distal axial
movement of said dosing component relative to said device body is
further operative to disengage said dose setting member from said
actuator to allow rotation of said dose setting member relative to
said actuator during dose delivery.
11. The medication delivery device of claim 8 in which said locking
mechanism includes mutually-facing teeth extending axially from
said coupling component and said dosing component.
12. The medication delivery device of claim 11 in which said dose
setting member includes an exposed circumferential surface for use
in rotating said dose setting member relative to said device body,
said dosing component including an inner wall and an outer wall,
said coupling component including a coupling wall received between
the inner and outer walls, said coupling component extending
distally beyond the inner wall and including a coupling portion
attached to the exposed circumferential surface of the dose setting
member.
13. The medication delivery device of claim 12 in which the
mutually facing teeth are formed on the coupling wall of said
coupling component and one of the inner and outer walls of said
dosing component.
14. The medication delivery device of claim 1 comprising a module
removably attached to said device body, said module including said
dosing component, said coupling component, and said electronics
assembly.
15. A dose detection module removably attachable to a medication
delivery device, the medication delivery device including a device
body, a dose setting member, and an actuator, the dose setting
member spiraling relative to the device body during dose delivery
in relation to the amount of dose delivery, the dose setting member
including an exposed circumferential surface for use in rotating
the dose setting member relative to the device body, and the
actuator spiraling with the dose setting member during dose setting
and translating without rotation relative to the device body during
dose delivery, said module comprising: a coupling component
configured to be axially and rotationally fixed to the dose setting
member; a dosing component having a first operating mode in which
said dosing component is axially and rotationally fixed to said
coupling component during a dose setting operation of the
medication delivery device, and a second operating mode in which
said dosing component is axially and rotationally fixed to the
actuator and in which said coupling component is rotatable relative
to said dosing component during a dose delivery operation of the
medication delivery device; and an electronics assembly attached to
said dosing component, said electronics assembly including a
rotation sensor operative to detect rotation of said coupling
component relative to said dosing component during dose
delivery.
16. The module of claim 15 in which said coupling component is not
in contact with said dosing component in the second operating
mode.
17. The module of claim 15 and further comprising a locking
mechanism rotationally locking said coupling component with said
dosing component in the first operating mode, said locking
mechanism including mutually-facing teeth extending axially from
said coupling component and said dosing component, the teeth being
configured to cause disengagement of said dosing component from
said coupling component in the event that a rotational force is
applied from said dosing component to said coupling component in
excess of a predetermined amount.
18. The module of claim 15 in which said dosing component includes
an inner wall and an outer wall, said coupling component including
a coupling wall received between the inner and outer walls, said
coupling component extending distally beyond the inner wall and
including a coupling portion configured to be attached to the
exposed circumferential surface of the dose setting member for
attaching said coupling component to the dose setting member.
19. The module of claim 18 in which the outer wall includes an
inwardly-directed shoulder having a proximally-facing surface, the
coupling wall including an outwardly-directed flange received
adjacent the proximally-facing surface of the shoulder.
20. The module of claim 18 in which the outer wall extends distally
to radially overlap at least a portion of the exposed
circumferential surface of the dose setting member upon
installation of said module onto the medication delivery
device.
21. A method of operating a medication delivery device, the
medication delivery device including a device body, a dose setting
member, and an actuator, the dose setting member spiraling relative
to the device body during dose delivery in relation to the amount
of dose delivery, the dose setting member including an exposed
circumferential surface for use in rotating the dose setting member
relative to the device body, and the actuator spiraling with the
dose setting member during dose setting and translating without
rotation relative to the device body during dose delivery, said
method comprising: attaching a module to the medication delivery
device, the module comprising a coupling component, a dosing
component, and an electronics assembly, the coupling component
including a coupling surface configured to be attached to the
exposed circumferential surface of the dose setting member and said
attaching comprising attaching the coupling surface to the exposed
circumferential surface to axially and rotationally fix the
coupling component to the dose setting member; placing the module
in a first operating mode with the dosing component axially and
rotationally locked to the coupling component; rotating the dosing
component relative to the device body to thereby rotate the dose
setting member to set a dose for delivery, the dosing component and
the coupling component rotating and translating together during
dose setting; axially displacing the dosing component, a first
distance in the distal direction toward the coupling component to
place the module in a second operating mode with the coupling
component rotationally unlocked from the dosing component and with
the dosing component axially and rotationally locked with the
actuator; axially displacing the dosing component, a further
distance in the distal direction to deliver the dose, the dose
setting member and the coupling component rotating relative to the
dosing component and the actuator during dose delivery; and
determining the dose delivery based on the rotation of the coupling
component relative to the dosing component during dose
delivery.
22. A dose detection module removably attachable to a medication
delivery device, the medication delivery device including a device
body, a dose setting member, and an actuator, the dose setting
member spiraling relative to the device body during dose delivery
in relation to the amount of dose delivery, the dose setting member
including an exposed circumferential surface for use in rotating
the dose setting member relative to the device body, and the
actuator spiraling with the dose setting member during dose setting
and translating without rotation relative to the device body during
dose delivery, said module comprising: a housing including a
circumferential wall, a proximal end wall, and a distal base wall
to abut with said device actuator, said proximal end wall
comprising a light pipe having a disc shape configured to receive
light axially and provide light radially in 360 degrees; the
housing having a first operating mode in which said housing is
axially and rotationally fixed relative to the dose setting member
during a dose setting operation of the medication delivery device,
and a second operating mode in which said housing is axially and
rotationally fixed relative to the dose setting component during a
dose delivery operation of the medication delivery device; and an
electronics assembly attached within said housing, said electronics
assembly including a rotation sensor arrangement operative to
detect relevant rotation between said housing and the dose setting
member during the dose delivery operation, and an indicator light
disposed distal to the light pipe, said indicator light operable to
emit light axially toward the light pipe.
23. The module of claim 22, wherein said light pipe is coupled to
the proximal end wall.
24. The module of claim 22, wherein said rotation sensor
arrangement comprises a metal ring and a tracking ring disposed
radially relative to the metal ring, said metal ring having a
plurality of contacting arms disposed radially relative to and in
contacting relationship with a conductive track disposed along the
tracking ring.
25. The module of claim 24, wherein said metal ring is disposed
radially outward of said tracking ring.
26. The module of claim 24, wherein said tracking ring includes a
ground segment disposed along a first portion of a perimeter of the
tracking ring, wherein the conductive track includes a plurality of
spaced conductive segments extending along a second portion of the
perimeter of the tracking ring.
27. The module of claim 26, wherein said first portion of the
perimeter of the tracking ring is 180 degrees, and the second
portion of the perimeter of the tracking ring is the other 180
degrees.
28. The module of claim 27, wherein the plurality of contacting
arms are paired spaced equally around an inner perimeter of the
metal ring such that at any rotational position of the tracking
ring relative to the inner perimeter, half of a total number of
contacting arms are engaged with the ground segment and the other
half of the total number of contacting arms are engaged with the
conductive segments.
29. The module of claim 22, wherein the electronics assembly
includes at least one electrical switches, the electrical switches
are positioned to be mechanically actuated with abutment between
the distal base wall of the housing with said device actuator.
Description
TECHNICAL FIELD
[0001] The present disclosure relates to an electronic dose
detection module for a medication delivery device, and more
particularly to an electronic dose detection module adapted to
removably attach to a proximal end portion of a medication delivery
device to detect a dose of medication delivered by the delivery
device.
BACKGROUND
[0002] Patients suffering from various diseases must frequently
inject themselves with medication. To allow a person to
conveniently and accurately self-administer medicine, a variety of
devices broadly known as injector pens or injection pens have been
developed. Generally, these pens are equipped with a cartridge
including a piston and containing a multi-dose quantity of liquid
medication. A drive member is movable forward to advance the piston
in the cartridge to dispense the contained medication from an
outlet at the distal cartridge end, typically through a needle. In
disposable or prefilled pens, after a pen has been utilized to
exhaust the supply of medication within the cartridge, a user, who
then begins using a new replacement pen, discards the entire pen.
In reusable pens, after a pen has been utilized to exhaust the
supply of medication within the cartridge, the pen is disassembled
to allow replacement of the spent cartridge with a fresh cartridge,
and then the pen is reassembled for its subsequent use.
[0003] Most injector pens and other medication delivery devices do
not include the functionality to automatically detect and record
the amount of medication delivered by the device to the patient
during the injection event. Rather, a patient must manually keep
track of the dose amount and time of each injection. Accordingly,
there is a need for a device that is operative to automatically
detect the dose delivered by the medication delivery device during
each injection event. Further, there is a need for such a dose
detection device to be removable and reusable with multiple
delivery devices.
SUMMARY
[0004] In a first aspect of the present disclosure, a medication
delivery device is provided in which the amount of a dose delivery
is determined based on the relative rotation of a dose setting
member during dose delivery. The device comprises a device body, a
dose setting member rotatably attached to the device body, and an
actuator attached to the device body. The actuator and the dose
setting member rotate and translate together during dose setting.
The actuator translates axially without rotation during dose
delivery, and the dose setting member rotates relative to the
actuator in relation to the amount of dose delivered. The device
further includes a coupling component attached to rotate and
translate with the dose setting member. A dosing component rotates
and translates with the coupling component during dose setting, and
is rotationally fixed to the actuator during dose delivery. The
amount of dose delivery is determined from the rotation of the
coupling component relative to the dosing component during dose
delivery.
[0005] In accordance with a second aspect of the present
disclosure, a dose detection module is provided for attachment to a
medication delivery device. The dose detection module includes a
coupling component comprising a first housing portion and a dosing
component comprising a second housing portion coupled to the first
housing portion. The first housing portion includes a coupling wall
and a coupling member. The coupling member is configured to
removably couple to a dose setting member of the medication
delivery device. The second housing portion is configured to engage
an actuator member of the medication delivery device and includes
an inner wall radially offset from the coupling wall. The inner
wall and the coupling wall are rotatable relative to each other
about an axis and axially moveable relative to each other along the
axis. The dose detection module further includes an electronics
assembly coupled to the second housing portion. The electronics
assembly includes a rotation sensor operative to detect a relative
rotation of the coupling wall and the inner wall.
[0006] Among other advantages in certain embodiments, an attachable
and detachable dose detection module is provided that is operative
to detect a delivered medication amount without changing the
functionality or operation of the delivery device. In some
embodiments, a same mechanical dose display is used by the user to
view the selected dose during use of the delivery device with or
without the module attached. In some embodiments, the sensing
system, such as sliding contacts for example, of the module does
not require sensor calibration by the end user. In some
embodiments, mechanical keying plus color coding of the module to
the delivery device allows for identification of a proper delivery
device and/or medication. In some embodiments, redundant sensors
are provided to add robustness to the dose sensing system. In some
embodiments, the sensing system records the size of the delivered
dose and monitors the elapsed time since the last dose. Other
advantages will be recognized by those of ordinary skill in the
art.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] The features and advantages of the present disclosure will
become more apparent to those skilled in the art upon consideration
of the following detailed description taken in conjunction with the
accompanying figures, wherein
[0008] FIG. 1 is a perspective view of an exemplary dose detection
module according to an illustrated embodiment coupled to a proximal
end of a medication delivery device;
[0009] FIG. 2 is a cross-sectional perspective view of the dose
detection module and medication delivery device of FIG. 1;
[0010] FIG. 3 is a perspective view of the proximal portion of the
medication delivery device of FIG. 1;
[0011] FIG. 4 is a partially exploded perspective view of the
proximal portion of the medication delivery device of FIG. 1;
[0012] FIG. 5 is a cross-sectional view of the dose detection
module of FIG. 1 attached to the proximal portion of the medication
delivery device, with an electronics assembly of the dose detection
module removed for illustrative purposes;
[0013] FIG. 6 is a side perspective view of a dose detection module
of FIG. 1 removed from the delivery device;
[0014] FIG. 7 is a top plan view of the dose detection module of
FIG. 6;
[0015] FIG. 8 is a bottom perspective view of the dose detection
module of FIG. 6;
[0016] FIG. 9 is an exploded top perspective view of the dose
detection module of FIG. 6;
[0017] FIG. 10 is an exploded bottom perspective view of the dose
detection module of FIG. 6;
[0018] FIG. 11 is a side perspective view of a flexible printed
circuit board (FPCB) of an electronics assembly of the dose
detection module of FIG. 6;
[0019] FIG. 12 is a bottom perspective view of the flexible printed
circuit board (FPCB) of FIG. 11;
[0020] FIG. 13 is a side view in longitudinal cross-section of the
dose detection module of FIG. 6 removed from a delivery device,
wherein the dose detection module is in a first operating mode
corresponding to a dose setting operation of a medication delivery
device;
[0021] FIG. 14 is a side view in longitudinal cross-section of the
dose detection module of FIG. 6 removed from a delivery device,
wherein the dose detection module is in a second operating mode
corresponding to a dose dispensing operation of a medication
delivery device;
[0022] FIG. 15 is an electrical schematic of an electronics
assembly according to an illustrative embodiment including a
rotational sensing system;
[0023] FIG. 16 is a partially exploded perspective view of
circumferential walls of the dose detection module of FIG. 1
including sliding contacts and a conductive track, as well as
schematic representations of the sliding contacts and the
conductive track;
[0024] FIG. 17 is cross-sectional perspective view of the flexible
printed circuit board (FPCB) of FIG. 11 positioned in a drum of the
dose detection module of FIG. 1 for electrical coupling to a
conductive track via spring contacts;
[0025] FIG. 18 is a schematic view of an exemplary rotational
sensing scheme of the dose detection module according to an
illustrative embodiment;
[0026] FIG. 19 is a schematic view of the exemplary rotational
sensing scheme of FIG. 18 illustrating a sensor and contact
arrangement when the dose detection module is in the first
operating mode;
[0027] FIG. 20 is a schematic view of the exemplary rotational
sensing scheme of FIG. 18 illustrating the sensor and contact
arrangement when the dose detection module is in the second
operating mode; and
[0028] FIG. 21 is a sequence of operation of the electronics
assembly of the dose detection module according to one exemplary
embodiment;
[0029] FIG. 22 is a cross-sectional view of an alternative dose
detection module;
[0030] FIG. 23 is a perspective view of an illustrative form of a
circumferential wall of a dose detection module;
[0031] FIG. 24 is a perspective view of an illustrative form of a
wall member of a dose detection module; and
[0032] FIG. 25 is a partial, cross-sectional view showing details
of the coupling of the circumferential wall of FIG. 23 with the
wall member of FIG. 24.
DETAILED DESCRIPTION
[0033] For the purposes of promoting an understanding of the
principles of the present disclosure, reference will now be made to
the embodiments illustrated in the drawings, and specific language
will be used to describe the same. It will nevertheless be
understood that no limitation of the scope of the invention is
thereby intended.
[0034] FIG. 1 illustrates a dose detection module 20 coupled to a
proximal end of a medication delivery device 10. Dose detection
module 20 is removably attached to delivery device 10 in that a
user may attach module 20 to and detach module 20 from the delivery
device 10. For example, prior to dose setting and injecting with
delivery device 10 (or in some embodiments of device 10 after dose
setting and prior to injecting), a user may couple module 20 onto
the end of device 10. Dose detection module 20 is operative to
detect the amount of medication dispensed by delivery device 10
while attached to device 10, as described herein. Module 20 is
further operative to store the detected dose in memory and transmit
a signal representative of the detected dose to a remote
communication device. After injecting the set dose with device 10
and detecting the delivered dose with module 20, the user may
remove the module 20 and, in the illustrative embodiment, reuse the
module 20 later with the same or a different delivery device 10
when performing another dose delivery.
[0035] Medication delivery device 10 is illustrated in FIG. 1 as an
injector pen 10 having a device body 11 comprising an elongated,
pen-shaped housing 12 and being configured to inject a medication
into a patient through a needle. Other shapes and forms of delivery
device 10, including devices that are not pen-shaped, may be
provided for use with dose detection module 20, including any
suitable needle or needleless delivery device. In one embodiment,
delivery device 10 is a disposable or prefilled injector pen, in
that after the quantity of medicine contained in a reservoir of the
pen is exhausted by multiple operations of the pen, the entire pen
is discarded rather than being reset and reloaded with a
replacement container of medicine. Alternatively, delivery device
10 may be a reusable injector pen wherein after the quantity of
medicine in the reservoir is exhausted by multiple operations of
the pen, the empty container is removed from the pen and a
replacement medicine container is loaded into the pen. Delivery
device 10 is operable by a user to select and then inject any one
of a number of different size doses, such as may be appropriate
with some therapeutics loaded therein, for example insulin.
Delivery device 10 is also adapted to deliver a dose in a specific
amount appropriate for other suitable types of therapeutics loaded
therein.
[0036] Housing 12 of delivery device 10 includes a distal portion
14, which is received within a pen cap 18, and a proximal portion
16. Referring to FIG. 2, distal portion 14 contains a reservoir or
cartridge 22 configured to hold the medicinal fluid to be dispensed
through its distal outlet end during a dispensing operation. The
outlet end of distal portion 14 is equipped with a removable needle
assembly 24 including an injection needle 26. A piston 28 is
positioned in fluid reservoir 22. An injecting mechanism positioned
in proximal portion 16 is operative to advance piston 28 towards
the outlet of reservoir 22 during the dose dispensing operation to
force the contained medicine through the needled end. The injecting
mechanism includes a drive member 30, illustratively in the form of
a screw, axially moveable relative to housing 12 to advance piston
28 through reservoir 22.
[0037] A dose setting member 32 is coupled to housing 12 for
setting a dose amount to be dispensed by device 10. In the
illustrated embodiment, dose setting member 32 is in the form of a
screw element operative to screw (i.e., simultaneously move axially
and rotationally) relative to housing 12 during dose setting and
dose dispensing. FIGS. 1 and 2 illustrate the dose setting member
32 fully screwed into housing 12 at its home or zero position. Dose
setting member 32 is operative to screw out in a proximal direction
from housing 12 until it reaches a fully extended position
corresponding to a maximum dose deliverable by device 10 in a
single injection.
[0038] Referring to FIGS. 2-5, dose setting member 32 includes a
cylindrical dial member 36 having a helically threaded outer
surface that engages a corresponding threaded inner surface of
housing 12 to allow dose setting member 32 to screw relative to
housing 12. Dial member 36 further includes a helically threaded
inner surface that engages a threaded outer surface of a sleeve 29
(FIG. 2) of device 10. In one embodiment, the outer surface of dial
member 36 includes dose indicator markings, such as numbers for
example, that are visible through a dosage window 40 to indicate to
the user the set dose amount. Dose setting member 32 further
includes a tubular flange 37 that is coupled in the open proximal
end of dial member 36 and is axially and rotationally locked to
dial member 36. Dose setting member 32 further includes a skirt or
collar 38 positioned around the outer periphery of dial member 36
at its proximal end. Skirt 38 is axially and rotationally locked to
dial member 36. Skirt 38 illustratively includes a plurality of
surface features 39 formed on the outer surface of skirt 38.
Surface features 39 are illustratively longitudinally extending
ribs and grooves that are circumferentially spaced around the outer
surface of skirt 38. An annular ridge 41 extends around the outer
periphery of skirt 38 for attachment of dose detection module 20.
The ribbed outer surface 39 and ridge 41 of skirt 38 cooperate to
provide a keyed attachment to a coupling component 106 (FIG. 5) of
dose detection module 20, as described herein.
[0039] Referring to FIGS. 3-5, an actuator 34 of delivery device 10
includes a clutch 44 which is received within dial member 36 and
includes an axially extending stem 47 (FIG. 5) at its proximal end.
Actuator 34 further includes a button 42 positioned proximally of
dose setting member 32 that is depressible by a user to initiate
the dose dispensing operation. Button 42 includes a disk-shaped
proximal end surface or face 43 and an annular wall portion 49
extending from a distal surface and spaced radially inwardly of the
outer peripheral edge of face 43 to form an annular lip there
between. A mounting collar 48 (FIG. 5) is centrally located on the
distal surface of button 42 within cylindrical wall portion 49.
Button 42 illustratively includes a recessed portion 45 centrally
located on proximal face 43, although proximal face 43
alternatively may be a flat surface. Proximal face 43 of button 42
serves as a push surface against which a force can be applied
manually (i.e. directly by user contact or through dose detection
module 20) to push actuator 34 in a distal direction. Collar 48 of
button 42 is secured to stem 47 of clutch 44, such as with an
interference fit or an ultrasonic weld, so as to axially and
rotatably fix together button 42 and clutch 44. A bias member 46,
illustratively a spring 46, is disposed between the distal surface
of button 42 and the proximal surface of sleeve 36 to urge actuator
34 and dose setting member 32 axially away from each other.
[0040] Delivery device 10 is operable in a dose setting mode and a
dose dispensing mode. In the dose setting mode of operation, the
dose setting member 32 is screwed or dialed relative to housing 12
to set a desired dose to be delivered by device 10. Dialing in the
proximal direction serves to increase the set dose, and dialing in
the distal direction serves to decrease the set dose. Dose setting
member 32 is adjustable in rotational increments (e.g., clicks)
corresponding to the minimum incremental increase or decrease of
the set dose during the dose setting operation (e.g., one increment
or click equals, for example, one unit or a half unit of
medication). The set dose amount is visible to the user via the
dial indicator markings shown through dosage window 40. Actuator
34, including button 42 and clutch 44, move axially and
rotationally with dose setting member 32 during the dialing in the
dose setting mode.
[0041] Once the desired dose is set and after device 10 is
manipulated so the injection needle 26 properly penetrates, for
example, a user's skin, the dose dispensing mode of operation is
initiated in response to an axial distal force applied to the
proximal face 43 of button 42, which causes axial movement of
actuator 34 in the distal direction (without rotation) relative to
dose setting member 32 towards housing 12. The axial force is
applied by the user directly to button 42 or to a dose detection
module 20 attached to button 42. The axial shifting motion of
actuator 34 compresses biasing member 46 and reduces or closes the
gap between button 42 and tubular flange 37, thereby rotationally
disengaging actuator 34 from dose setting member 32 (e.g.,
rotationally disengaging clutch 44 from tubular flange 37) to allow
relative rotation there between. In particular, dose setting member
32 rotatably uncouples from actuator 34 to allow back driving
rotation of dose setting member 32 relative to actuator 34. As
actuator 34 is continued to be axially plunged without rotation by
compression of button 42, dial member 36 screws back into housing
12 as it spins relative to button 42 and the dose markings that
indicate the amount still remaining to be injected are visible
through window 40. As dose setting member 32 screws down distally,
drive member 30 is advanced distally to push piston 28 through
reservoir 22 and expel medication through needle 26 (FIG. 2).
During the dose dispensing operation, the amount of medicine
expelled from the device is proportional to the amount of axial
movement and to the amount of rotational movement of the dose
setting member 32 as the dial member 36 screws back into housing
12. The injection is completed when the internal threading of dial
member 36 has reached the distal end of corresponding outer
threading of sleeve 29 (FIG. 2), at which time pen 20 is once again
arranged in a ready state or zero dose position as shown in FIGS. 1
and 3.
[0042] Further details of the design and operation of an exemplary
delivery device 10 may be found in U.S. patent application Ser. No.
10/567,196, filed Feb. 3, 2006 and entitled Medication Dispensing
Apparatus with Triple Screw Threads for Mechanical Advantage, now
U.S. Pat. No. 7,291,132, the entire disclosure of which is
incorporated by reference herein.
[0043] Referring to FIGS. 5-10, dose detection module 20 includes a
housing assembly 100 comprising a coupling component 101 including
a first housing portion 102 and a dosing component 103 including a
second housing portion 104 coupled to first housing portion 102. As
described herein, first and second housing portions 102, 104 are
rotatable relative to each other about a longitudinal axis and are
axially moveable relative to each other along the axis. First
housing portion 102 includes a coupling wall 112 (FIGS. 5, 9, 10),
illustratively in the form of a cylinder 112, and a coupling member
106 fixed to a distal end of coupling wall 112. Coupling wall 112
and coupling member 106 may be fixed together via any suitable
fastening means, such as a weld, snap fit, threaded interface,
etc., or alternatively may be integrally formed as a single
component. In the illustrative embodiment, coupling member 106
includes an annular ridge 131 that extends axially from the
proximal end forming an annular shoulder 133 between ridge 131 and
an outer surface 132 of coupling member 106 (see FIG. 9). The
distal end of coupling wall 112 includes circumferentially spaced
tabs 136 (FIG. 10) that snap fit into corresponding
circumferentially spaced notches 134 formed in ridge 131 to
rotationally and axially fix coupling member 106 to coupling wall
112. When coupled together, the distal end of coupling wall 112
abuts annular shoulder 133 of coupling member 106.
[0044] Coupling member 106 includes an annular ring portion 108
sized to receive dose setting member 32 and to engage an outer
surface of dose setting member 32, illustratively skirt 38, for
attaching first housing portion 102 to delivery device 10. As
illustrated, outer surface 132 tapers radially inwardly from
shoulder 133 to ring portion 108 such that a proximal end diameter
of coupling member 106 is larger than a distal end diameter of
coupling member 106. An inner surface 109 of ring portion 108
includes a plurality of surface features 110, illustratively
variably sized projections and grooves, that are sized to engage
corresponding surface features 39 (e.g., grooves) of skirt 38 for
coupling thereto. In the illustrated embodiment, surface features
110 of coupling member 106 couple to annular ridge 41 of skirt 38
(FIG. 5) via a snap fit or an interference fit, although any other
suitable fastening mechanism may alternatively be used to couple
first housing portion 102 to dose setting member 32.
[0045] In the illustrative embodiment, surface features 110 and 39
are sized, shaped, and spaced to provide mechanical keying of dose
detection module 20 to delivery device 10. In particular, in the
illustrative embodiment, detection module 20 is mechanically keyed
via surface features 110 to be compatible with a specific type or
types of delivery devices having compatible surface features 39,
such as based on medication type, concentration, strength, volume,
and/or formulation, as well as cartridge size or other aspects of
the corresponding delivery device. In some embodiments, electronics
assembly 140 of module 20 is pre-programmed to operate based on the
compatible delivery device(s) and/or medication. Such mechanical
keying serves to reduce the likelihood that detection module 20 is
used with an incorrect delivery device and/or medication. With the
mechanical key feature, module 20 must be in proper rotational
alignment with skirt 38 of device 10 to slide and snap coupling
member 106 onto skirt 38. Coupling member 106 illustratively
includes a projection 135 on its outer surface 132 that serves as a
visual guide or reference for rotationally aligning module 20 to
dose setting member 32. Other keying features, such as color
coding, may be used to identify a correct module 20 for a
corresponding delivery device 10.
[0046] Referring still to FIGS. 5-10, second housing portion 104
includes a drum 113 (FIGS. 5, 9, and 10) and a cap portion 116
coupled to a proximal end of drum 113. Drum 113 illustratively
includes inner wall 114 and a disc-shaped base wall 126 at a distal
end of inner wall 114. Inner wall 114 illustratively includes an
upper wall portion 138 and a lower wall portion 139 having a
greater outer diameter but a same inner diameter as upper wall
portion 138, forming an annular ridge 141 on the outer surface of
inner wall 114. Cap portion 116 includes an end wall 118 positioned
orthogonally to circumferential wall 114. End wall 118
illustratively includes a distal wall portion 119 and a proximal
wall portion 121 coupled to distal wall portion 119 at a centrally
located mounting interface 123 via a snap fit, interference fit,
ultrasonic weld, or other suitable coupling mechanism. Cap portion
116 further includes an outer wall 120 radially spaced apart from
and substantially parallel to inner wall 114. In the illustrated
embodiment, coupling wall 112 of first housing portion 102 is
positioned in the gap formed radially between outer wall 120 and
inner wall 114 of second housing portion 104. End wall 118 of cap
portion 116 includes a mounting collar 124 (FIGS. 5 and 10) axially
extending from and centrally located on distal wall portion 119.
Upper wall portion 138 of inner wall 114 is fixed to mounting
collar 124 via any suitable coupling mechanism, such as ultrasonic
weld or interference fit for example.
[0047] In the illustrated embodiment, a ring-shaped indicator light
122 is integrated into end wall 118 between distal wall portion 119
and proximal wall portion 121. Indicator light 122 illustratively
includes one or more light-pipes 144 illuminated by one or more
light-emitting diodes (LEDs) of electronics assembly 140. Light
pipe 144 is disc shaped and includes a centrally located mounting
collar 145 that is coupled to slots 147 formed in distal wall
portion 119 of end wall 118. Indicator light 122 is electronically
controlled by a processor of electronics assembly 140 for providing
visual feedback to a user of the operational state of detection
module 20. For example, indicator lights 122 may illuminate in
different colors based on module 20 being in particular power
state, a dose detecting mode, a wireless transmitting mode, a
faulted or error state, or any other suitable operational state. In
an alternative embodiment, indicator lights 122 may also indicate
to a user that module 20 is improperly attached to device 10.
[0048] Still referring to FIGS. 5-10, when module 20 is attached to
delivery device 10, a distal surface of base wall 126 abuts
proximal end surface 43 of button 42 (FIG. 4). Illustratively, the
distal surface of base wall 126 includes a thin, disc-shaped
friction pad 142 having a central opening. Pad 142 provides
frictional resistance (e.g., via surface roughness and/or adhesive)
between base wall 126 and button 42 such that second housing
portion 104 remains rotationally coupled to button 42 during
operation of module 20 with device 10. Base wall 126 of drum 113 in
some embodiments may include a centrally located, axially extending
projection (not shown) configured for receipt within recessed
portion 45 of button 42, such as for coupling and/or alignment of
button 42 and base wall 126.
[0049] As illustrated in FIGS. 8 and 10, centrally located
apertures 128 are formed in base wall 126 for receiving electrical
switches 130 of electronics assembly 140. Switches 130 are
mechanically actuated or triggered by engagement with the proximal
surface 43 of button 42. In the illustrative embodiment,
electronics assembly 140 is operative to power on from a low power
mode or powered off mode, or to enter a low power mode from a
powered off mode, upon proper attachment of housing assembly 100 to
button 42 based on actuation of switches 130, as described in
greater detail herein. While two apertures 128 and two switches 130
are illustrated, any suitable number of apertures 128 and switches
130 may be provided and spaced appropriately on base wall 126 for
detecting proper attachment of module 20 to delivery device 10.
[0050] In the illustrated embodiment, when dose detection module 20
is attached to delivery device 10, first and second housing
portions 102, 104 and dose setting member 32 are coaxial and are
thus operative to rotate together about a same longitudinal axis
during a dose setting operation of delivery device 10. In addition,
first and second housing portions are operative to move axially
together with the dose setting member 32 along the longitudinal
axis during the dose setting operation and axially relative to each
other along the longitudinal axis in response to an axial force on
second housing portion 104 to start the dose dispensing operation.
While coupling wall 112 and inner wall 114 of respective first and
second housing portions 102, 104 illustratively extend 360 degrees
about the longitudinal axis of module 20, coupling wall 112 and
inner wall 114 alternatively may extend a portion of the full
circumference about the axis. In other words, walls 112, 114 may
include one or more breaks in the respective wall somewhere along
the perimeter rather than being continuous walls as
illustrated.
[0051] Dose detection module 20 is configured for operation in at
least a first operating mode and a second operating mode. In the
illustrated embodiment, the first operating mode corresponds to the
dose setting operation of delivery device 10, and the second mode
corresponds to the dose dispensing operation of delivery device 10.
In the first operating mode, first and second housing portions 102,
104 are at a home position axially wherein second housing portion
104 is not axially compressed relative to first housing portion
102. In this first mode, first and second housing portions 102, 104
are rotationally locked together by a locking mechanism,
illustratively a tooth and slot coupling. Referring again to FIGS.
9 and 10, the proximal end of coupling wall 112 of first housing
portion 102 includes a radially extending annular lip 160 having a
plurality of circumferentially spaced slots 162 formed therein.
Slots 162 of lip 160 are each sized to receive a tooth or tongue
164 formed on the outer surface of upper wall portion 138 of inner
wall 114. Illustratively, four teeth 164 are spaced 90 degrees
apart around upper wall portion 138, and twenty slots 162 are
equally spaced around lip 160, although any suitable number of
teeth 164 and slots 162 may be provided. In the illustrative
embodiment, the number of slots 162 is the same as the number of
rotational increments or clicks to which dose setting member 32 of
device 10 may be set in one complete rotation of dial member 36
relative to housing 12. The multiple slots 162 allow first housing
portion 102 and second housing portion 104 to lock together in the
first mode in multiple relative rotational positions, with more
slots 162 providing more possible relative positions. In an
alternative embodiment, slots 162 may be formed on inner wall 114
and tongues formed on coupling wall 112. Other suitable rotational
locking mechanisms may be provided.
[0052] In general, dosing component 103 has a first operating mode
during dose setting in which the dosing component is axially and
rotationally fixed to the coupling component. In this first mode,
dosing component 103 may be grasped by the user and rotated
relative to device body 11. Due to the connections between dosing
component 103 and coupling component 101, and between coupling
component 101 and dose setting member 32, the rotation of dosing
component 103 results in rotation of dose setting member 32 and a
dose is set. During dose setting, actuator 34, including dose
button 42, is connected by way of clutch 44 to dose setting member
32 and spirals with dose setting member 32 relative to device body
11.
[0053] In one embodiment, dosing component 103 includes inner wall
114 and outer wall 120, and coupling component 101 includes
coupling wall 112 received between the inner and outer walls. Dose
setting member 32 includes an exposed circumferential surface,
optionally including surface features 39, for use in rotating the
dose setting member relative to the device body. Coupling wall 112
extends distally beyond inner wall 114 and includes a coupling
portion attached to the exposed circumferential surface of the dose
setting member in order to attach the coupling component 101 to the
dose setting member 32. In another aspect, outer wall 120 extends
distally to radially overlap at least a portion of the exposed
circumferential surface of the dose setting member.
[0054] Dosing component 103 is rotationally locked with coupling
component during dose setting. As previously indicated, this may be
accomplished by way of a variety of locking mechanisms.
Illustratively, coupling wall 112 is received in the gap between
inner wall 114 and outer wall 120. As described, the locking
mechanism may comprise mechanical features, such as teeth 164
received within slots 162 (FIG. 9), or complementary shaped,
mutually-facing teeth extending axially from the coupling and
dosing components (FIG. 25). As these examples demonstrate, the
teeth in either event may, for example, be formed on the coupling
wall of the coupling component and one of the inner and outer walls
of the dosing component. In a further aspect, to reduce the risk of
damage to the medication delivery device, the locking mechanism is
configured to cause disengagement of the dosing component from the
coupling component in the event that a rotational force is applied
from the dosing component to the coupling component in excess of a
predetermined amount.
[0055] Illustratively, the locking mechanism is configured also to
allow for disengagement upon axial movement of the dosing component
toward the coupling component. Once disengaged, the coupling
component is free to rotate relative to the dosing component. As
also described, axial movement of the actuator in the direction of
the dose setting member results in clutch 44 disconnecting the
rotational engagement of the actuator with the dose setting member.
In one aspect, pressing the housing assembly 100 moves dosing
component 103 closer to coupling component 101 and coupling
component 101 is thereby rotationally disengaged from dosing
component 101. This occurs before actuator 34 moves a sufficient
distance to initiate dose delivery. In another aspect, a wake-up
switch is provided to cause relevant components of electronics
assembly 140 to activate in time to detect the dose delivery. In
another aspect, pressing housing assembly 100 disengages dosing
component 103 from coupling component 101 and engages the wake-up
switch, and subsequent distal movement presses dose button 42 and
dose delivery occurs.
[0056] As shown, although not required, the disengagement of dosing
component 103 from coupling component 101 may occur such that there
is no contact between those two components once disengaged. For
example, referring to FIG. 14 the upper end of coupling wall may be
spaced apart from the interior of distal wall portion 119.
Providing such a space avoids contact between coupling wall 112 and
outer wall 120 which could otherwise provide frictional resistance
to rotation of coupling component 101 relative to dosing component
103 during dose delivery.
[0057] In the second mode of module 20, the locking mechanism is
disengaged, and first and second housing portions 102, 104 are
rotatable relative to each other. An axial movement or compression
of second housing portion 104 relative to first housing portion 102
is operative to transition module 20 from the first mode to the
second mode by disengaging the locking mechanism to allow relative
rotation of first and second housing portions 102, 104 about the
longitudinal axis of module 20. In particular, the axial movement
of second housing portion 104 towards first housing portion 102
causes teeth 164 to axially slide out of corresponding slots 162 to
rotationally uncouple first and second housing portions 102,
104.
[0058] In general, dosing component 103 has a second operating mode
during dose delivery in which coupling component 101 is rotatable
relative to the dosing component 103. In this second mode, dosing
component 103 is axially and rotationally fixed to actuator 34.
Dosing component 103 is axially fixed in that the dosing component
bears against actuator 34 as the housing assembly 100 is pressed
distally to deliver a dose. Further, dosing component 103 is
rotationally fixed to actuator 34 either by a frictional engagement
or by other locking means as previously described. During dose
delivery, actuator 34, including dose button 42, is pressed by the
user and translates axially, while being held from rotating
relative to device body 11. Since clutch 44 has released the
rotational connection between actuator 34 and dose setting member
32, the dose setting member spirals back into device body 11.
[0059] FIG. 13 illustrates dose detection module 20 in the first
operating mode with first and second housing portions 102, 104
rotationally locked together by the locking mechanism and at an
axially home position. In the first mode, the overall height of
module 20 is a first height H.sub.1, and a gap 170 extends between
lip 160 and end wall 118, as illustrated in FIG. 13. In the first
mode with module 20 coupled to delivery device 10, a rotational or
screw force on module 20 (such as applied to outer wall 120 or any
other user accessible portion) causes corresponding rotation and
axial motion of dose setting member 32 to operate delivery device
10 in the dose setting mode described herein.
[0060] FIG. 14 illustrates dose detection module 20 in the second
operating mode with second housing portion 104 compressed towards
first housing portion 102 by an axial force to disengage the
rotational locking mechanism. In the second mode, the overall
height of module 20 is a second height H2 that is less than the
first height H.sub.1, and gap 170 is reduced or eliminated between
lip 160 of coupling wall 112 and end wall 118 of cap portion 116,
as illustrated in FIG. 14. In the second mode with module 20
coupled to delivery device 10, the axial force which compresses
module 20 is transferred to actuator 34 to compress button 42 and
thereby rotationally disengage actuator 34 from dose setting member
32, causing dose setting member 32 to screw back into housing to
operate delivery device 10 in the dose dispensing mode. During the
dose dispensing operation of delivery device 10, first housing
portion 102 screws (moves axially and rotationally) with dose
setting member 32 while second housing portion 104 remains
rotationally fixed while moving only axially with dose setting
member 32.
[0061] Referring to FIGS. 11 and 12, a flexible printed circuit
board (FPCB) 146 of electronics assembly 140 is illustrated having
a plurality of electronic components 150 disposed on each of a
plurality of sections, each section comprising a single- or
multi-layer circuit board. Electronic components 150 include
light-emitting diodes (e.g., disposed on the top section for
illuminating light pipes 144), a microcontroller unit (MCU) (e.g.,
including at least one processor core and memory), a communication
device including a wireless transmitter/transceiver, an integrated
real-time clock with power-on management circuit, etc., as
described herein with respect to FIG. 15. A battery 152,
illustratively a coin cell battery, is provided for powering
components of FPCB 146. Each section or leaf of FPCB 146 is
separated by a non-conductive spacer 148 (FIG. 12) to space apart
the FPCB sections and electrical components. As illustrated in FIG.
12, a pair of alignment posts 154 extends from the distal end of
FPCB 146 for rotationally aligning FPCB 146 to base wall 126 of
drum 113.
[0062] Referring to FIGS. 13 and 14, FPCB 146 of electronics
assembly 140 is shown housed in an interior space or compartment
149 formed by inner wall 114, base wall 126, and cap portion 116 of
second housing portion 104. FPCB 146 is illustratively coupled at a
distal end to base wall 126 and at a proximal end to end wall 118
of cap portion 116. Electrical switches 130 extend through base
wall 126 and frictional pad 142 (FIG. 5) for engagement with button
42 of delivery device 10, as described herein.
[0063] FIG. 15 illustrates an exemplary electrical schematic of
electronics assembly 140. In one embodiment, each component 150
illustrated in FIG. 15 with the exception of sliding contacts 172,
174 is coupled directly to FPCB 146 and is powered by battery 152,
although other suitable physical configurations may be provided.
Electronics assembly 140 includes a microcontroller unit (MCU) 200
comprising at least one processing core and internal memory. MCU
200 includes control logic operative to perform the operations
described herein including detecting a dose delivered by delivery
device 10 based on a detected relative rotation of first and second
housing portions 102, 104 during the dose dispensing operation. MCU
200 is operative to store the detected dose in local memory (e.g.,
internal flash memory or on-board EEPROM 206). MCU 200 is further
operative to wirelessly transmit a signal representative of the
detected dose to a paired remote electronic device, such as a
user's smartphone, over a Bluetooth low energy (BLE) or other
suitable short or long range wireless communication protocol.
Illustratively, the BLE control logic and MCU 200 are integrated on
a same circuit.
[0064] MCU 200 is in communication with a pair of LEDs 208 for
controlling illumination of indicator light 122, with EEPROM 206
for storing and/or reading data, and with a temperature sensor 210
for monitoring a temperature of module 20. A clock signal (e.g., 20
MHz) is provided to MCU 200 by clock generator 212 for
synchronization. MCU 200 is operative to pair to the remote
electronic device and transmit status and dose information signals
to the remote device via antenna 214 using BLE protocol.
[0065] An integrated real-time clock with first-time on power
management (RTC/FTO) circuit 202 is provided on FPCB 146 for
managing power up control of module 20, e.g., upon a first use from
a powered off state. RTC/FTO circuit 202 communicates with MCU 200
and EEPROM 206 over inter-integrated circuit (I2C) protocol and
synchronizes with MCU 200 using a clock signal from clock generator
216.
[0066] Electronics assembly 140 of FIG. 15 includes a rotation
sensor operative to detect the relative rotation of coupling wall
112 and inner wall 114 during the dose dispensing operation of
device 10 to detect the delivered dose amount. The rotation sensor
of the illustrated embodiment includes a plurality of sliding
electrical contacts 172, 174 in communication with MCU 200.
Alternatively, other suitable rotational sensors may be provided,
including optical, acoustic, magnetic, mechanical switches, or
other suitable rotation sensors.
[0067] Referring to FIG. 16, a first set of electrical contacts in
the form of a metal ring 172 is coupled to coupling wall 112 of
first housing portion 102. Metal ring 172 is provided as a single
conductor fixed around the outer periphery of wall 112 and
including a plurality of equally spaced conductive sliding contact
arms or points 173, illustratively four arms 173, extending through
openings in coupling wall 112. All sliding contacts 173 of metal
ring 172 are electrically connected together, as represented with
the representative schematic 230 of metal ring 172. Similarly, a
second set of electrical contacts 174 in the form of a conductive
track 174 is disposed around lower wall portion 139 of inner wall
114 of second housing portion 104 and are in sliding engagement
with contact arms 173 of metal ring 172. Accordingly, first and
second contact sets 172, 174 are positioned in the gap that extends
between walls 112, 114 (see FIG. 12). The conductive track 174 is
comprised of a ground segment 175 extending around a first portion
of the perimeter of inner wall 114 and a plurality of spaced
conductive segments 176 extending around a second portion of the
perimeter of inner wall 114. In the illustrative embodiment, ground
segment 175 extends 180 degrees around the perimeter of inner wall
114 and conductive segments 176 extend the other 180 degrees around
the perimeter of inner wall 114, as illustrated in FIG. 16 with
representative schematic 232 of conductive track 174. Conductive
segments 176 are spaced such that a non-conductive segment or
portion of inner wall 114 extends between each segment 176 to
provide electrical isolation between segments 176 to form the track
174.
[0068] Conductive track 174 is illustratively coupled to an outer
surface of wall portion 139 and includes connecting conductors 177
extending through openings in drum 113 to the interior of drum 113
for electrical coupling to FPCB 146. In the illustrative
embodiment, each conductive segment 176 and ground segment 175 has
at least one corresponding conductor 177 extending inside the wall
portion 139. MCU 200 of electronics assembly 140 is in electrical
communication with each conductor 177 for sensing the relative
position of the sliding contacts 172, 174. Referring to FIG. 17, a
plurality of spring contacts 236 are disposed around the interior
bottom surface of base wall 126 and electrically connect conductors
177 to corresponding metal contact pads 238 (FIG. 12) of FPCB 146
for routing the rotational sensing lines to corresponding pins of
MCU 200. In the illustrative embodiment, fourteen pairs of spring
contacts 236 and contact pads 238 are provided corresponding to ten
pairs for conductive segments 176 (for five sensing signals), two
for ground segment 175, and two for a start of injection (SOI)
conductive segment 178. Alternative contacts 236 may be provided,
such as zebra connectors, pogo-pins, conductive tape, and soldered
connections for example.
[0069] As illustrated with the representative schematic 180 of FIG.
18, sliding contacts 173 of first contact set 172 are spaced
equally, illustratively 90 degrees apart, around the inner
perimeter of wall 112 such that, at any rotational position of
coupling wall 112 relative to inner wall 114, half of the total
number of sliding contacts 173 (illustratively two sliding contacts
173) are engaged with the ground segment 175 and the other half of
the total number of sliding contacts 173 (illustratively two
sliding contacts 173) are engaged with the conductive track
segments 176. In the illustrative embodiment, the portion of track
174 formed by conductive segments 176 includes two redundant
conductive segment portions. In particular, conductive segments 176
include two sets of redundant segments spaced 90 degrees apart,
wherein each corresponding segment pair represents a bit provided
to a pin of MCU 200. As illustrated in FIG. 18, ten conductive
segments 176 are provided for a five-bit system with two conductive
segments 176 (one is redundant) for each bit. Accordingly, with the
four contact arms 173 of coupling wall 112, track 174 has a
resolution of 18 degrees corresponding to 20 different sensed
rotational positions of coupling wall 112 relative to inner wall
114. The 20 different sensed relative rotational positions of walls
112, 114 correspond to the 20 different rotational incremental dose
setting positions of dose setting member 32 described herein. Each
bit pair of conductive segments 176 is in electrical communication
with a corresponding sensor 182. Put another way, each sensor 182
is electrically coupled to two conductive segments 176 spaced 90
degrees apart, thereby providing bit redundancy and code repetition
every five steps. In the illustrated embodiment, each sensor 182
includes an input pin of MCU 200.
[0070] Table 184 of FIG. 18 illustrates the exemplary coding scheme
of the sliding contact system of the illustrative embodiment. For
illustrative purposes, table 184 shows only the coding scheme for
half of a full revolution (ten incremental positions) of contact
ring 172 relative to conductive track 174, and the second half of
the full revolution is a repetition of the coding scheme shown in
table 184. The contact ring 172 shorts to ground a single sensor
signal line at each of the five positions. As such, in this coding
scheme, the bit corresponding to the pair of segments 176 engaged
with the two contact points 173 has a logical value zero, while the
remaining bits have a logical value of one. In table 184, each CODE
column (one through five) corresponds to a sensor 182. When wall
112 is in a first rotational position with contact points 173
engaged with the pair of segments 176 coupled to the first sensor
182, the first bit changes to logical zero and the remaining bits
remain logical one. When coupling wall 112 moves to a second
rotational position with the same contact points 173 engaged with
the segment pair 176 coupled to the second sensor 182, the first
bit changes back to logical one, the second bit changes to logical
zero, and the remaining bits stay at logical one. Accordingly, two
bits change for each incremental change in the relative rotational
position of walls 112, 114. In the illustrated embodiment, control
logic of MCU 200 is operative to filter out unwanted bit sequences
detected during transitions between bit states, such as bit
sequences generated due to mechanical part tolerances and/or
bouncing during bit state transitions.
[0071] In an alternative embodiment, conductive track 174 may
provide a four-bit system with eight conductive segments 176
extending 180 degrees around wall 114 including four redundant
conductive segments 176. Other suitable numbers of conductive
segments 176 and corresponding bits, such as a three bit or six-bit
system, may be provided.
[0072] Referring to FIGS. 19 and 20, another schematic
representation of the sliding contact system of FIG. 18 is
illustrated. Conductive track 174 further includes a conductive
segment 178 that is parallel to and axially offset from ground
segment 175 and that extends the length of ground segment 175
(e.g., 180 degrees around wall 114). Conductive segment 178 serves
as a start of injection (SOI) track and is used to distinguish
between the first operating mode (dialing) and the second operating
mode (injecting) of dose detection module 20. FIG. 19 illustrates
the axial position of contact ring 172 in the first operating mode
when second housing portion 104 is not axially compressed and is
rotationally locked to first housing portion 102, i.e., prior to
start of injection. In this mode, contact arms 173 of contact ring
172 engage conductive segment 178 but not ground segment 175.
Conductive segment 178 is electrically connected to an input pin
183 of MCU 200 and normally is set high (logic 1) to enable start
of injection detection. Each sensor input is also pulled high due
to internal resistors of MCU 200 and segment 178 being disconnected
from ground. When not in the injecting mode (when second housing
portion 104 is not compressed), MCU 200 is operative to force pin
183 low (to ground), such as for periodically checking the five
sensor inputs 182 and determining a relative rotational position
based on one of the sensor inputs being shorted to ground.
[0073] FIG. 20 illustrates the axial position of contact ring 172
in the second operating mode when second housing portion 104 is
axially compressed and is rotationally uncoupled from first housing
portion 102. In the second mode, inner wall 114 moves axially
relative to contact ring 172 such that two contact arms 173 of
contact ring 172 engage ground segment 175 but not conductive
segment 178. By transitioning the two contact arms 173 from segment
178 (normally at logic 1) to ground segment 175, one of the sensor
inputs is shorted to ground and thereby MCU 200 detects the start
of injection. In one embodiment, MCU 200 wakes up to a full power
mode upon detecting start of injection. Accordingly, MCU 200 is
operative to distinguish between the first and second modes of
operation of dose detection module 20. After metal ring 172
transitions to the axial position shown in FIG. 20, module 20 is
ready to count the rotational increment changes as coupling wall
112 rotates relative to inner wall 114 to detect the delivered dose
of medication. In the illustrated embodiment, MCU 200 is configured
to detect the relative rotation of housing portions 102, 104 by
counting the sensor state changes which correspond to rotational
increments of dose setting member 32 throughout the injection
event. The total number of rotational increments corresponds to the
amount of medication delivered by device 10. When metal ring 172
transitions back to segment 178, all sensor inputs are pulled high
(logic 1) and MCU 200 thereby detects that the injection is
complete.
[0074] Upon completion of an injection, pressure is removed from
the module and contact ring 172 returns to the position shown in
FIG. 19. In this position, the system is operable to continuously
or occasionally detect the rotational position of second housing
portion 104 relative to first housing portion 102 while the device
is at rest. In particular, two of the contact arms 173 are engaged
with conductive SOI segment 178 and the other two contact arms 173
are engaged with one pair of the sensor inputs S1-S5, which thereby
provides an indication of the relative, at-rest rotational position
of walls 112 and 114. The SOI track 178 is driven low by the
processor which pulls low the sensor touched by the contact arms so
that the sensor status can be checked in the resting position.
[0075] In one embodiment, the last resting position of a previous
injection is taken as the first step for a new injection so that a
jump in the first step may be captured and corrected if
appropriate. If some steps are missed during rotation, or even the
first or the last step, the SOI reading is used to recover the dose
injected accurately. In this embodiment, because the SOI is only
driven low at the end of the injection, no additional current
consumption occurs.
[0076] Optionally, a slight increased diameter in correspondence
with the resting position is put in place, such as by slightly
increasing the diameter of the wall or SOI trace only at the
resting position. This increases the likelihood of reliably reading
the resting position without increasing the frictional torque
between housing portions during injecting.
[0077] Referring again to FIG. 15, pen presence switches 130 are
routed to an input of RTC/FTO circuit 202 for signaling the
attachment of module 20 to pen 10. In one embodiment, one switch
130 is normally open (N.O.) and the other switch 130 is normally
closed (N.C.). When module 20 is detached, a presence signal input
of circuit 202 is low (logic 0) and module 20 remains powered off.
When module 20 is attached to pen 10, the N.O. switch 130 closes
and the N.C. switch 130 opens to output a presence signal to the
input of circuit 202. In response to the pen presence signal,
circuit 202 enables MCU 200 to power on. In one embodiment, in
response to the signal MCU 200 powers on to a low power/deep sleep
mode (e.g., 150 nA) and waits for detection of sliding contact
movement before transitioning to fully powered on. In another
embodiment, in response to the signal MCU 200 fully powers on
before entering the low power mode (sleep state) after a
predetermined period of inactivity (e.g., no detection of sliding
contact movement). The pen presence signal may serve to avoid
unwanted wake up of the system 140 when module 20 is not attached
to the device 10 (i.e. due to an unwanted sliding contact movements
during module 20 handling).
[0078] In one embodiment, RTC/FTO circuit 202 is always powered on
(even in the powered-off mode of MCU 200) since circuit 202 has low
power consumption. In one embodiment, whenever switches 130 are
engaged MCU 200 is always at least in the low power mode. Module
200 is operative to go from the fully powered on mode to the low
power mode under MCU 200 control (such as when module 200 is
disconnected from device 10 and/or after a predetermined period of
inactivity), and wake-up from this state is done by actuation of
switches 130 or a detected transition of a sliding contact
sensor.
[0079] FIG. 21 illustrates an exemplary sequence of operations of
the electronics assembly 140 of FIG. 15.
[0080] In an exemplary mode of use for attachment of module 20 to
device 10, the user aligns the visual alignment feature(s) of
module 20 (e.g., feature 135 of FIG. 6) and device 10 and module 20
is snap fitted to dose setting member 32 of device 10. The locking
mechanism (e.g., teeth 164 and slots 162) ensure proper alignment
of the rotational sensor. When module 20 touches button 42 of
device 10, the presence switches 130 trigger an MCU 200 power on
from a powered off state. In one embodiment, any detection of false
injection event during attachment is disregarded by MCU 200. When
module 20 is powered on and ready to be used, indicator lights 122
signal green.
[0081] In an exemplary mode of use for dialing a dose, module 20 is
rotated relative to housing 12 of device 10, and such rotation is
translated to dose setting member 32 to screw dial member 36 up to
the desired dose amount. In an illustrated embodiment, electronic
module 20 is unaware of the dialing event since no signal variation
is typically captured by module 20 during this phase.
[0082] In an exemplary mode of use for injecting a dose, cap
portion 116 of module 20 is pushed relative to housing 12 to start
injection. The axial force disengages the locking mechanism in
module 20 and the clutch in delivery device 10, and first housing
portion 102 is free to rotate relative to second housing portion
104 and dial member 36 is free to rotate relative to button 42 of
device 10. The initial small relative axial movement of housing
portions 102, 104 (during disengagement of the locking mechanism)
some sensors will transition from logic 1 to logic 0 as soon as the
contact arms 173 touch the ground pad 175, which wakes up the MCU
200 that will start booting/check/sensing monitoring. When
injection ends, the user releases the cap portion 116, and MCU 200
captures the injection event until a certain timeout period
following de-assertion of cap portion 116, stores the dose
information, provides LED feedback (e.g., dose captured,
transmitting, etc.), and starts BLE activity in order to
automatically update the app running in the remote smartphone. In
one embodiment, the BLE activity encompasses an advertising phase
(with a Timeout of 30 sec) and a connection phase where relevant
data are transmitted. In case of a transmission failure, manual
sync of module 20 with the smartphone is possible later to transmit
the dose information. Following transmission, module 20 transitions
again to deep sleep state (low power mode).
[0083] In an exemplary mode of use for detaching module 20 from
device 10, module 20 is detached by pulling module 20 with the
required force away from device 10. In an illustrative embodiment,
when module 20 is disconnected, the presence switches 130 will be
de-asserted. In response, MCU 200 will prepare the system for a
power off of MCU 200, and the powered off mode will be maintained
until the next module 200 attachment to a device 10.
[0084] Referring to FIG. 22, a further illustrative embodiment of a
module 300 is shown. In FIG. 22, module 300 includes a continuous
wall member 302 extending from a lower portion 304 to an upper
portion 306. Lower portion 304 is coupled with skirt 38. Lower
portion 304 includes an annular ring portion 308 sized to engage an
outer surface of dose setting member 32, illustratively skirt 38,
for attaching lower portion 304 to delivery device 10. An inner
surface 310 of lower portion 304 includes a plurality of surface
features, illustratively variably sized projections and grooves,
which are sized to engage corresponding surface features (e.g.,
grooves) of skirt 38 for coupling thereto, such as by a snap fit or
an interference fit, although any other suitable fastening
mechanism may alternatively be used to releasably couple lower
portion 304 of wall member 302 to dose setting member 32. In the
illustrative embodiment, the surface features provide mechanical
keying of dose detection module 300 to delivery device 10.
[0085] Upper portion 306 of wall member 302 includes an
outwardly-extending flange 312 which is received against an
internal shoulder 314 of outer wall 120. When it is desired to
remove module 300 from skirt 38 of the medication delivery device
10, the user pulls the module upwardly while grasping the body of
the pen. The cooperation of flange 312 and shoulder 314 provides a
firm, mechanical connection which transfers upward force on wall
120 of module 300 to separate the module from skirt 38. This avoids
stress being applied to other portions of the module assembly,
including for example the weld or frictional fit of inner wall 114
to mounting collar 124.
[0086] Referring to FIGS. 23-25, there is shown an illustrative
coupling system between outer wall 120 and wall member 302. In FIG.
23 a perspective view of outer wall 120 is shown to include a
series of upwardly-directed teeth 320 equally spaced around the
interior surface 322. In FIG. 24 there is shown a perspective view
of wall member 302. Wall member 302 includes a series of downwardly
directed teeth 324 spaced around the exterior surface 326. Teeth
324 are shaped and positioned to be received within teeth 320 when
wall member 302 is received within outer wall 120. Illustratively,
outer wall 120 may include 20 teeth and wall member 302 may include
four teeth, although other suitable configurations may be provided.
The teeth are configured to readily mate upon movement together.
For example, the teeth 324 are shaped such that they are received
in any one of twenty discrete positions delineated by teeth 320,
which may be provided to correspond to the discrete positions for
setting the units of a medication dose.
[0087] During dose setting, outer wall 120 is spring-biased in the
direction causing teeth 320 to engage with teeth 324. This
rotationally couples together outer wall 120 and wall member 302,
thereby coupling the dose setting member and the module. When the
module is pushed to deliver a dose, the complementary teeth 320 and
324 separate, causing wall member 302 to uncouple from, and spin
relative to, outer wall 120.
[0088] Referring to FIG. 25, further exemplary details as to the
complementary teeth 320 and 324 are provided. Teeth 324 are shown
in FIG. 25 in the coupling position such as exists during dose
setting, and outer wall 120 is in its uppermost position relative
to wall member 302. The engagement of the complementary teeth
provides sufficient engagement in this condition to have rotation
of outer wall 120 effect a dose setting. The larger surface area
provided by the module facilitates this dose setting by the user.
Excessive torqueing of the system is prevented by the cooperation
of the complementary teeth. The teeth are configured to cause
disengagement in the event that a rotational force is applied in
excess of a predetermined amount. This disengagement may be caused
to occur, for example, by providing tooth profiles which cause the
angled end portions of teeth 324 to ride up along the angled end
portions of teeth 320, thereby moving wall member 302 axially away
from outer wall 120. The angled end portions of teeth 324 and teeth
320 also guide the re-engagement of teeth 324 with teeth 320 and
ensure that they are engaged with each other as wall member 302 and
outer wall 120 move axially back toward each other.
[0089] Illustratively, there is provided in a second aspect a dose
detection module removably attachable to a medication delivery
device. The medication delivery device includes a device body, a
dose setting member, and an actuator. The dose setting member
spirals relative to the device body during dose delivery in
relation to the amount of dose delivery. The dose setting member
also includes an exposed circumferential surface for use in
rotating the dose setting member relative to the device body. The
actuator spirals with the dose setting member during dose delivery
and translates without rotation relative to the device body during
dose delivery.
[0090] The module comprises a coupling component, a dosing
component, and an electronics assembly. The coupling component is
configured to be axially and rotationally fixed to the dose setting
member. The dosing component has a first operating mode in which
the dosing component is axially and rotationally fixed to the
coupling component during a dose setting operation of the
medication delivery device. The dosing component has a second
operating mode in which the dosing component is axially and
rotationally fixed to the actuator and the coupling component is
rotatable relative to the dosing component. The electronics
assembly includes a rotation sensor operative to detect rotation of
the coupling component relative to the dosing component during dose
delivery.
[0091] The module may be removably attached to the medication
delivery device. While mounted to the medication delivery device,
the module does not interfere with the normal operation of the
device. However, the module provides a dosing component that is
useful during dose setting to rotate the dose setting component,
and which is useful during dose delivery to allow detection of
relative rotation of the coupling component which is indicative of
the amount of dose delivered.
[0092] The disclosed module and medication delivery device allow
for an expedient method for determining dose delivery.
Illustratively, there is disclosed a method of operating a
medication delivery device of the type described herein. In
particular, the medication delivery device includes a device body,
a dose setting member, and an actuator. The dose setting member
spirals relative to the device body during both dose setting and
dose delivery, and includes an exposed circumferential surface for
use in rotating the dose setting member relative to the device
body. The actuator spirals with the dose setting member during dose
setting and translates without rotation relative to the device body
during dose delivery. The method comprises attaching a module to
the medication delivery device, the module comprising a coupling
component, a dosing component, and an electronics assembly. The
coupling component includes a coupling surface configured to be
attached to the exposed circumferential surface of the dose setting
member, and the coupling surface is attached to the exposed
circumferential surface to axially and rotationally fix the
coupling component to the dose setting member.
[0093] The module is placed in a first operating mode with the
dosing component axially and rotationally locked to the coupling
component. The dosing component is rotated relative to the device
body to thereby rotate the dose setting member to set a dose for
delivery. The dosing component and the coupling component rotate
and translate together during dose setting. The dosing component is
then axially displaced a first distance in the distal direction
toward the coupling component to place the module in a second
operating mode. In the second operating mode, the coupling
component is no longer rotationally locked to the dosing component,
and the dosing component is axially and rotationally locked with
the actuator. The dosing component is then axially displaced a
further distance in the distal direction to deliver the dose.
During dose delivery, the dose setting member and the coupling
component rotate relative to the dosing component and the actuator.
A rotation sensor is used to detect the rotation of the coupling
component relative to the dosing component, and the amount of dose
delivery is derived therefrom.
* * * * *